Getting Started in eIRB: The Basics JHM eIRB Getting Started in eIRB: The Basics

eIRB Accounts: JHED Users JHED User accounts are automatically created upon first login. No self-registration process is required.

eIRB Accounts: JHED Users If you forget your JHED ID or JHED password: Use the links (i.e., Forgot Password?) below, or contact JHED directly at jhed@jhmi.edu or call the JHED IT Support Center at 410-955-HELP.

eIRB Accounts: Non-JHED Users Non-JHED Users must email the eIRB help desk (jhmeirb@jhmi.edu) to set up an account.

eIRB Accounts: Non-JHED Users Only Non-JHED users have the ability to change the password assigned to them. Select “Account Management” on the left navigation bar and follow the prompts.

Investigator Home Page Left Navigation Bar Account Management (Non-JHED Users Only) eIRB Training My IRB Studies Create New Application Studies List Studies are listed by project type

Investigator Tabs Action Required (default tab) Researcher Prep Studies that have been returned for PI response Researcher Prep Studies that have never been submitted In Process Studies awaiting Pre-IRB or IRB review Approved Studies that have been Approved All My IRB Studies All approved, disapproved, expired, terminated, disapproved or withdrawn studies with which you are associated

Create New Application Available under “My IRB Studies” Click “Create…” to begin a NEW eIRB application.

Create Further Study Action Locate Approved application Click on the application name/title to open the Approved application workspace

Create Further Study Action On the left side of the workspace under “Create Further Study Action”, select “Create…”

Create Further Study Action Select the type of Further Study Action (FSA) you would like to create, and click “Continue” to complete the FSA.

Add/Update/Delete Documents Add Documents You must select “Add ” to: Upload a New Document

Add/Update/Delete Documents Update Documents You must select “Update” to: Upload a Revised document View the history of a document Delete a document (4. change dropdown from “Submitted” to “Deleted”)

Add/Update/Delete Documents Use “Update” to change the status of the document to “Deleted” Click “OK” A “strikethrough” will appear through the document name. Click “Update” to upload the correct document Remember to change the status to “Submitted” before clicking “OK”.

Reviewer Notes All applications are subject to a Pre-IRB review as well as an IRB reviewer. Issues that require a response are referred to as “Reviewer Notes”.

Reviewer Notes IRB staff will add reviewer notes to the applicable sections of the eIRB application. The PI/study team must respond to each reviewer note and make revisions to the application (if applicable) Select “Click here to respond…” to enter a response.

Reviewer Notes Click “Ok” to save your response. Your response will be highlighted in green when complete.

Reviewer Notes To edit your response, click on “Study Team Response”. Click OK to save.

Reviewer Notes You can also track and respond to reviewer notes using the “Reviewer Notes” tab on the Application Workspace.